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New Test Increases Sensitivity of HPV Detection in Cancer

Cancer panel reveals new insights in HPV cancers

CHICAGO – Researchers from Sanford Health and Chronix Biomedical today announced that results from a pilot study demonstrating the utility of a new cancer panel to detect previously undetected viral and cancer mutations are to be reported in a poster presentation titled “Detection of novel HPV mutations and chromosomal number imbalance (CNI) in oropharyngeal and laryngeal cancer using next-generation sequencing (NGS)" (Abstract #6072) at the American Society of Clinical Oncology annual meeting being held from May 30 through June 3 in Chicago.

The panel identified human papilloma virus (HPV) sequences undetected by conventional laboratory tests as well as new unreported HPV mutations. It is estimated that each year there are approximately 30,000 cases of HPV-associated cancers in the United States.

In the study, researchers applied advanced next-generation sequencing (NGS) techniques to identify tumor-associated mutations in 10 laryngeal and oropharyngeal cancer patients who underwent standard chemo-radiation therapy. As a control, two samples from relapsing respiratory papillamatous patients were analyzed. The single-blinded study looked at biopsied DNA from patients who were either positive or negative by conventional HPV testing. The new test identified HPV sequences in six of the samples of which conventional testing only identified four. The new test agreed with conventional testing in the other five samples that were negative for HPV sequences. Additionally, the new test identified mutations to the HPV sequences previously unreported on HPV databases. Further, the chromosome number imbalance discovered was consistent with oropharyngeal cancers.

Analyzing a patient’s cancer for genetic mutations is the basis for predicting treatment outcomes using various cancer drugs and protocols. Currently, most cancer mutation panels focus on less than 1 percent of the cancer genome with limited predictive value. The preliminary finding from this study is the basis for a larger planned study designed to match these viral and cancer mutations to clinical outcomes using a vastly expanded panel. By using a more extensive mutation panel, the accuracy of genetic testing should be vastly increased for predicting optimal treatment decisions.

“These powerful new technologies are allowing us to better understand the role of viruses in cancer and the ability to make better treatment decisions patient-by-patient,” said John Lee, M.D., a physician scientist at Sanford and principal investigator of the study. “In the next study, we plan to follow up using a blood-based liquid biopsy to determine in real-time the efficacy of the treatment."

“Current technology uses limited amounts of data to make important treatment decisions. This new technology greatly expands the amount of medically critical data we can use to increase the accuracy of treatment decision-making. This new cancer panel has the potential to significantly enhance patient care while greatly reducing the cost to the healthcare system,” said study lead-author Howard B. Urnovitz, Ph.D., chief executive officer of Chronix Biomedical.

“This new comprehensive genetic cancer panel will make a major contribution with great benefit for cancer patients because accurate prediction of treatment efficacy can guide therapeutic options, which can be confirmed in weeks through a liquid biopsy,” said Professor Ekkehard Schütz, M.D., Ph.D., chief technology officer of Chronix Biomedical.

About Sanford Health

Sanford Health is an integrated health system headquartered in the Dakotas and is now the largest, rural, not-for-profit health care system in the nation with locations in 126 communities in nine states. In addition, Sanford Health is in the process of developing international clinics in Ghana, Israel, Mexico and China.

Sanford Health includes 39 hospitals, 140 clinic locations and 1,360 physicians in 81 specialty areas of medicine. With more than 26,000 employees, Sanford Health is the largest employer in North Dakota and South Dakota. The system is experiencing dynamic growth and development in conjunction with nearly $1 billion in gifts from philanthropist Denny Sanford. These gifts are making possible the implementation of several initiatives, including global children's clinics, multiple research centers and finding cures for type 1 diabetes and breast cancer. For more information, visit sanfordhealth.org.

About Chronix Biomedical

Chronix Biomedical is a molecular diagnostics company developing tests for cancer and organ transplant integrity, including a cancer mutation panel and liquid biopsies for cancer patients and organ transplant patients. Chronix is currently collaborating with cancer groups to provide critical data for their research studies. Chronix expects to complete several larger studies by the end of 2014 and to have its new cancer panel and liquid biopsy tests commercially available by 2015.

Chronix is privately held with headquarters in San Jose, California, and laboratories in Brookings, South Dakota and Göttingen, Germany. It was the first Company to use next-generation sequencing on cell-free DNA. The Company has two issued patents on the detection of cell-free DNA and RNA, and four patents pending focused on cancer mutations and their detection through liquid biopsies. In addition, the company has a patent pending for the detection transplant organ rejection. For additional information please visit www.chronixbiomedical.com.